BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons with Tetraplegia

Not Applicable

Recruiting

• Conditions: Spinal Cord Injuries; Brain Stem Infarctions; Amyotrophic Lateral Sclerosis; Tetraplegia; Locked in Syndrome; Muscular Dystrophy
• Interventions: Device: Placement of the BrainGate2 sensor(s) into the motor-related cortex

• Registration Number: NCT00912041
• Lead Sponsor: Leigh R. Hochberg, MD, PhD.

Brief Summary

The purpose of this study is to obtain preliminary device safety information and demonstrate proof of principle (feasibility) of the ability of people with tetraplegia to control a computer cursor and other assistive devices with their thoughts.

Detailed Description

The goal of the BrainGate2 research and development project is to identify the core methods and features for a medical device that could allow people with paralysis, including severe speech impairment, to recover a host of abilities that normally rely on the hands or on speech.

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-06-01
• Study First Submitted QC: 2009-06-02
• Study First Posted: 2009-06-03
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-21
• Primary Completion: 2038-09
• Study Completion: 2038-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• Clinical diagnosis of spinal cord injury, brainstem stroke, muscular dystrophy, amyotrophic lateral sclerosis or other motor neuron disorders
• Complete or incomplete tetraplegia (quadriplegia)
• Must live within a three-hour drive of the Study site
• (There are additional inclusion criteria)

Exclusion Criteria

• Visual impairment such that extended viewing of a computer monitor would be difficult even with ordinary corrective lenses
• Chronic oral or intravenous steroids or immunosuppressive therapy
• Other serious disease or disorder that could seriously affect ability to participate in the study
• (There are additional exclusion criteria)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BrainGate	Placement of the BrainGate2 sensor(s) into the motor-related cortex	BrainGate Neural Interface System

Primary Outcome Measures

Name	Time	Method
The primary endpoint of this Study is to determine the safety of the BrainGate2 Neural Interface System.	One year post-implant evaluation period

Secondary Outcome Measures

Name	Time	Method
To investigate the feasibility of BrainGate2 and to establish the parameters for a larger clinical study, such as appropriate neural decoding algorithms, sample size, indices of measurement, success criteria, and endpoints.	Course of the study

Trial Locations

Locations (5)

University of California, Davis; 🇺🇸 Sacramento, California, United States

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States

Emory University School of Medicine; 🇺🇸 Atlanta, Georgia, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Providence VA Medical Center; 🇺🇸 Providence, Rhode Island, United States